Method of obtaining and treating compounds from ozonized unsaturated vegetable oils for pharmaceutical compositions for medical and veterinary use

ABSTRACT

The invention relates to a method of obtaining a stable product of natural vegetable origin, particularly macadamia oil, which is treated in a reactor in which the oil is exposed to a continuous flow of ozone and, subsequently to a feedback of end gases under the influence of an electromagnetic field. The treatment and production time is significantly reduced under specific conditions in terms of temperature, pressure, gas streams, pH and substance saturation volumes with ozone, which is obtained in an oxygen-fed generator. According to the invention, the reaction causes the formation of a novel compound: topically-applied ozone cream which is used to treat infectious processes. The inventive ozonized cream can penetrate and regenerate the epithelial tissue without causing skin irritations associated with similar known treatment methods. The compound is stable and the fundamental nature thereof does not tend to alter.

TECHNICAL FIELD OF THE INVENTION

This invention involves the field of application of topical compositionscontaining ozonized vegetable oils or their derivatives in which two ormore oils coexist.

The skin, which is the largest organ, is exposed to damage from a widevariety of natural and synthetic agents that can reside in it, penetrateit, destroy its structure (because the agent is caustic or causes burnsor irritations), or damage it because of toxins. Among the agents thatattack the skin are numerous microorganisms.

This invention is designed to protect and restore the skin's normalstructure without causing secondary effects.

Also included in this field is the process of obtaining pure macadamiaoil under the influence of ozone using a reactor that exposes thereacting substances to strong electromagnetic fields and refluxes orreverse feeding that significantly shorten the processing time.

PRIOR ART

It has been known for many years that when unsaturated oil compounds andthe families of 8 or more double-carbon-bond isomers are subjected toozone, they produce ozonized oils, becoming oxygen carriers withbacteria-killing properties.

They also stimulate enzyme processes (in enzymes such as superoxidedismutase, acid phosphatase hydrogenase, and others) and are used in thecosmetics industry and in skin- and acne-care products.

In U.S. Pat. No. 4,451,480, De Villez claims that when used externally,ozonized olive, jojoba, and peanut oils have antimicrobial properties,but the addition of certain substances, like propyl paraben, butylparaben, or lanolates, can cause skin irritation. The present invention,which uses pure macadamia oil, causes no secondary effects.

In U.S. Pat. No. 5,190,979, Herman writes about adding products likepropylene glycol, propyl paraben and glycerine to ozonized linaloolcream for treating acne and adding glycerine and polyentilene glycol,among other compounds, for treating burns. He does not mention whetherthese produce secondary effects.

No synthetic product is added to this invention that uses macadamia oiland the results of tests on human beings showed no secondary effects.Prior researchers performed their work using rabbit skin.

DISCLOSURE OF THE INVENTION

The invention specifically involves the ozonation of macadamia oil andthe derivative fatty acids, monoterpene oxides, and aldehydes.

The ozone may be added to the double bonds present in the structure ofthe oils through the Criegee process that generates the formation ofozonides. These ozonides are unstable in hydrophilic environments andbreak down, causing the rupture of the chain at that point. But inhydrophobic environments, these ozonides are stable, leading to anincrease in the substance's molecular weight since three atoms of oxygenare incorporated into the molecular structure for each double bond. Thiscan lead to the substance's change of state.

This reaction process is slow, and energy is required to accelerate it.This energy can be added through heat or other specific forms, such asan electromagnetic field, that effects the movement of each moleculethat rotates because of the energy. The rotation of molecules,positioned by the field that is applied, results in an increase in theinternal temperature of the system and a higher frequency of collisionsbetween molecules. The energy that is applied through electromagneticfields is suitable for the ozone-gas diffusion process in the oil-liquidmedium and the formation reaction of ozonides.

The fatty acids, which are essential components of the human body, enterin the form of triacylglycerol, are a source of energy, and play animportant role in the membrane structure. In 1929, Burr discovered thatsome are resynthesized by animals, while others are produced by plants.It is known that palmito, stearic, palmitoleic, and oleic have a dualorigin; linoleic and alpha linoleic are produced by plants. Thereactions are produced by stages of desaturation and elongation.66-dalton enzymes (Okayasu et. al. 1981) specifically produce a doublebridge between carbons 6 and 7 and are strategically located at thebeginning of the biosynthetic scheme.

When the enzymes are located in the endoplasmic reticular membrane(Brener 1974), an action has recently (sic) been observed in themitochondrial fraction.

The invention involves the pure macadamia oil being exposed to ozone ina reactor using an electromagnetic field in a frequency range between140 and 650 MHz (the work done by Rasplicka, from Yanko industries, usedvery low frequencies—50-60 Hz).

A 2-kg load of macadamia oil is used with a 5 and 25 lt/min flow ofozone, at a concentration that varies between 4 and 26 g/h. Thetemperature range between the initial and final phases is between 2 and35 degrees Celsius, and the working and process time is between 8 and 25hours. Other inventors achieved a process time of between 180 and 300hours (Washuttl et. al., U.S. Pat. No. 5,183,911).

The micro-bubbling through the reactor column should be continuous,especially in order to achieve the solid consistency that results whenworking at a lower atmospheric pressure, one that corresponds to analtitude of 2800 meters above sea level (distinguishing this processfrom those of other investigators who work at sea level, Ozone ResearchCenter, National Center of Scientific Research-Cuba) and withenvironmental temperatures that fluctuate between 5 and 20 degreesCelsius. Another accomplishment is a mechanism of reverse-feeding in theupper part of the column so that the elements that are attracted arereincorporated in the process. All of these procedures yield surprisingand unexpected positive results. These new procedures were not developedby similar processes, which sets them apart from the methods of otherresearchers who do not reinject the gases and do not use electromagneticfields. (Herman et. al U.S. Pat. Nos. 4,983,637 and 5,190,979).

The compound obtained using this procedure is a cream with an ozonesaturation of between 60% and 95% that can be used directly on the skin;and it has been shown [that the cream] does not cause secondary effects.

EXAMPLES

The following examples are provided to illustrate the invention andshould not be considered as limits on its reach.

Example 1

Obtaining ozonized cream from macadamia oil.

A 2-kg load of pure macadamia oil is placed in the reactor. The ozone isdiffused through the reactor under the influence of the electromagneticfield. The flow of gas is from 5 to 25 liters per minute and the ozoneconcentration varies from 4 to 26 g/h. The ozonization takes place forseveral hours, until the mix has a doughy consistency. The whole time,the exhaust gases are fed back into the process. Then the temperature ischanged and the final product is extracted without using any additionalchemical. After noting the pH, the product is ready to be bottled andlabeled.

Efficacy Trial 1. Third-Degree Burns.

The cream was applied to 8 patients with extensive second- andthird-degree burns on the skin and with skin grafts showing signs ofrejection.

The treatments were applied after removing the dead tissue. A generouslayer of the product was applied to the extensive effected areas ofskin, which was then covered with sterile gauze. These treatments, whichwere repeated daily for 6 weeks, achieved the following results:

The skin completely regenerated

No additional infections were observed

The gauze was less likely to stick to the wound

The skin grafts were not rejected

There was a reduction in the formation of scabs, which are hard andpainful. Furthermore, when the burns are treated with conventionalpharmaceuticals, the scabs leave marks when they fall away.

There were no keloids (excessive growth of soft and elevated tissue thatcan occur in third-degree burns)

The patient with the largest burn area, having burns covering 18% of hisbody, took 6 weeks. Patients with less extensive burns recovered morequickly. The study was performed double blind.

Efficacy Trial 2. Bed Sores.

Six patients were chosen who had developed bed sores from multipletraumas or quadriplegia after suffering a traffic accident.

The ulcers showed a loss of [tissue matter] in an average area of 4 to15 cm². The patients were between 22 and 70 years old and showed nosigns of metabolic diseases, so the cream was applied twice a day for 10days.

Antibiotics were not used and the general management of the patients wasmade based on the condition of the main pathology.

After 10 days, the following results were observed:

The ulcers closed completely.

No scabs formed.

The color of the skin was uniform compared with the skin in thesurrounding area, except in colored patients.

The new skin tissue showed no signs of being fragile as occurs on thesurface of skin that has been under pressure and has received reducedblood flow.

In the three patients who had smaller wounds, the wounds closed in lessthan 10 days. The study was double blind and evaluatedskin-rehabilitation creams with synthetic active ingredients.

1.-12. (canceled)
 13. A method for obtaining an ozonized macadamia oilcomposition, comprising the steps of: a. placing a quantity of puremacadamia oil in a vertical reactor; and, b. diffusing ozone in aconcentration of between 4 and 26 grams per hour through the reactorunder influence of an electromagnetic field.
 14. The method of claim 13,further comprising the step of reinjecting exhaust gases into thereactor.
 15. The method of claim 13 where the step of diffusing ozonelasts for a period of between 8 and 25 hours.
 16. The method of claim 13where the electromagnetic field has a frequency of between 140 and 650MHz.
 17. The method of claim 13 where the ozone has a flow rate ofbetween 5 and 25 liters per minute.
 18. The method of claim 13 where thestep of diffusing ozone has an initial phase temperature and a finalphase temperature and where said final phase temperature is greater thansaid initial phase temperature.
 19. The method of claim 13 where thestep of diffusing ozone causes the ozonized macadamia oil composition tohave a doughy consistency.
 20. An ozonized macadamia oil compositionwhere ozone comprises between 50% and 95% of the total composition, thecomposition made by the method of claim
 13. 21. The ozonized macadamiaoil composition of claim 20, further comprising one of gadoleic orarachidic acid, C16 to C20 in a concentration between 0.05% and 8% oftotal weight.
 22. The ozonized macadamia oil composition of claim 20,further comprising one of terpene aldehyde or monoterpene oxide in aconcentration between 0.05% and 4% of total weight.
 23. The ozonizedmacadamia oil composition of claim 20, further comprising one of 1,8cineol, 16 methyl heptadecanoic acid, or 14 methyl hexadecanoic acid ina concentration between 0.05% and 3% of total weight.
 24. The ozonizedmacadamia oil composition of claim 20 where said composition is a creamhaving a crystalline quality.
 25. The ozonized macadamia oil compositionof claim 20 where said composition is applied topically to skin whichhas had its anatomical structure affected.
 26. The ozonized macadamiaoil composition of claim 20 where said composition is impregnated into asterile cotton gauze to a point of saturation.
 27. An ozonized macadamiaoil composition comprising a plurality of constituent elements, whereeach of the plurality of constituent elements has a concentrationbetween 0.05% and 99.5% of total weight of the composition, thecomposition made by the method of claim 13.